Epicondylitis of the Elbow Clinical Trial
Official title:
Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm Soft Tissue System (Implants and Instrumentation) in the Elbow - A Multicenter Retrospective Consecutive Study
Verified date | December 2023 |
Source | Zimmer Biomet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The study is a multicenter, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect data confirming safety, performance and clinical benefits of the ToggleLoc 2.9 mm Soft Tissue System when used for soft tissue to bone fixation in the elbow. The primary objective is the assessment of performance by analyzing soft tissue to bone healing in the elbow. The secondary objective is the assessment of safety and clinical benefits. Safety will be evaluated by recording and analyzing the incidence and frequency of complications and adverse events. Relation of the events to device, instrumentation and/or procedure will be specified. Clinical benefits will be assessed by recording patient-reported outcome measures (PROMs) at the longest follow-up after surgery (minimum one year).
Status | Active, not recruiting |
Enrollment | 83 |
Est. completion date | February 2024 |
Est. primary completion date | February 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients who received the ToggleLoc 2.9 mm Soft Tissue device for soft tissue to bone fixation in the elbow. - Patients 18 years or older and skeletally mature. - Patients capable of understanding the surgeon's explanations and following his/her instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study. Exclusion Criteria: - Infection. - Patient conditions including blood supply limitations, and insufficient quantity or quality of bone or soft tissue. - Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions. - Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation of the device. - Patients who have any condition that would in the judgment of the Investigator place the patient at undue risk or interfere with the study. - Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant). - Off-label use. |
Country | Name | City | State |
---|---|---|---|
Spain | ASEPEYO Hospital | Madrid | |
United States | OrthoVirginia | Fairfax | Washington |
Lead Sponsor | Collaborator |
---|---|
Zimmer Biomet |
United States, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Soft tissue to bone healing in the elbow | Assessment of performance by analyzing soft tissue to bone healing in the elbow. The principal investigator will clinically evaluate the study elbow to assess if soft tissue to bone healing has occurred using a combined assessment of pain, ROM and activity level. | From operation to the study completion, minimum 1 year post-op. | |
Secondary | Incidence and frequency of revision | Safety will be evaluated by recording and analyzing the incidence and frequency of revisions. A Kaplan Meier survival curve will be calculated. | From operation to the study completion, minimum 1 year post-op. | |
Secondary | EuroQol five-dimensional Health Questionnaire (EQ-5D-5L) | Assessment of patient-reported outcome measures (PROMs): The EuroQol fivedimensional Health Questionnaire (EQ-5D-5L) is a generic instrument. The EQ-5D-5L is scored on a 0 to 100 mm scale. 0 mm represents "the worst..." and 100 mm represents "the best health you can imagine". | From pre-operative to the study completion, minimum 1 year post-op. | |
Secondary | Oxford Elbow Score (OES) | Assessment of patient-reported outcome measures (PROMs): The Oxford Elbow Score (OES) consists of 12 questionnaire items with five original response options each and is specifically designed and developed for assessing outcomes of elbow surgery. The score will be on a scale from 0 (worst) to 48 (best). | From pre-operative to the study completion, minimum 1 year post-op. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06440928 -
Results of Cervical Segmental Mobilization in Patients With Chronic Lateral Epicondylitis
|
N/A | |
Not yet recruiting |
NCT05238090 -
Efficacy of a Stretching Protocol for Lateral Epicondylitis
|
N/A | |
Recruiting |
NCT06442618 -
Effectiveness of Extracorporeal Shockwave Therapy and Nutraceutical Supplementation in the Treatment of Epicondylitis: a Clinical Trial
|
N/A | |
Completed |
NCT02710682 -
Tendon Fenestration Versus Surgery for the Treatment of Chronic Lateral Epicondylosis
|
N/A | |
Completed |
NCT03788161 -
Virtual Reality and Post-dry Needling Soreness
|
N/A | |
Completed |
NCT04856228 -
Radial Tunnel Syndrome in Resistant Lateral Epicondylitis
|
N/A | |
Completed |
NCT01525043 -
Study to Evaluate the Efficacy of the Synera Patch Compared to Naproxen Sodium for Epicondylitis of the Elbow
|
Phase 4 |